Washington Week: Wait for ACO Regs Finally Over

WASHINGTON -- For everyone who was waiting for the much-anticipated release of the Affordable Care Act-mandated accountable care organization proposed regulations, the wait ended this week.

The Department of Health and Human Services had been saying all month the proposed regulations would be unveiled before the end of March, and, sure enough, they were released on March 31.

Centers for Medicare and Medicaid Services (CMS) Director Donald Berwick, MD, projected that the collaborative model of caring for Medicare patients could save up to $960 million over the next three years.

The proposed rule reveals who the government will allow to lead an accountable care organization, or ACO: physicians in group practices; networks of individual practices; hospitals that employ physicians; partnerships among these groups and other healthcare providers; and any "other Medicare providers and suppliers as determined by the Secretary."

The government will accept comments on its proposed rule for 60 days and issue a final rule later this year.

Panel Nixes Link Between Food Dye, Hyperactivity

The FDA's Food Advisory Committee voted 11-3 that there is not enough evidence to conclude that artificial dyes used to color foods contribute to hyperactivity in children.

But the panel didn't rule out that food coloring might have a negative behavioral effect on kids. The committee agreed that more studies need to be done and split over whether thousands of food products that contain dyes should have to carry labels warning there may be some risk of consuming the chemical coloring.

The FDA does not have to follow the advice of its advisory committees, but it often does.

But the committee's negative assessment of the studies linking dye to hyperactivity in kids means that juices, candies, cereals, yogurts, and hundreds of other everyday foods will likely maintain their brighter-than-bright hues.

The vote came at the end of the panel's two-day meeting, which was held at the request of the Center for Science in the Public Interest (CSPI), which petitioned the FDA in 2008 to ban eight of the nine FDA-approved food dyes, including Yellow No. 5, Red 40, and Blue No. 1.

Disease Clusters Focus of Hearing

A congressional committee held a hearing on disease clusters, and a new report highlights 42 locations throughout the U.S. that have alarmingly higher incidences of certain diseases, including cancer and birth defects.

The report, released by the Natural Resources Defense Council (NRDC) and the National Disease Clusters Alliance, surveyed 13 states in which so-called "disease clusters" had been identified by media reports and by local and state health agencies.

In most cases, the diseases were suspected to be caused by environmental factors, Gina Solomon, MD, MPH, senior scientist at the NRDCand one of the authors of the report, said in testimony before the Senate Committee on Environment and Public Works.

One particularly bizarre cluster is occurring in Camp Lejeune, N.C., where 64 male Marines living on the base have been diagnosed with breast cancer. Contaminated drinking water at Camp Lejeune is thought to be a possible carcinogen, said Solomon.

Sens. Barbara Boxer (D-Calif.) and Mike Crapo (R-Idaho) have introduced a bill that would increase coordination between federal agencies to investigate potential disease clusters. Currently, the Centers for Disease Control and Prevention does not investigate most reports of clusters.

High Court Sides With Drug Companies

Public hospitals and clinics cannot sue pharmaceutical companies that may have overcharged for drugs covered by federal price ceilings, the Supreme Court ruled in an 8-0 decision.

Sole authority to enforce drug pricing agreements for public healthcare facilities rests with the federal Health Resources and Services Administration (HRSA), the court decided, reversing an appeals court ruling that stemmed from a class-action case brought by California's Santa Clara County against AstraZeneca and eight other drug companies.

At issue was whether so-called 340B facilities -- a reference to the section of the Public Health Services Act that sets ceilings on drug prices for public healthcare facilities, tied to the Medicaid drug rebate program -- could seek damages from drug firms they believed were charging more for drugs than allowed under the statute.

Out of 47 indications granted fast-track status, benefits have not yet been confirmed in 21, mostly because trials are ongoing, wrote John R. Johnson, MD, of the FDA's oncology drugs office, and colleagues in an article published online in Journal of the National Cancer Institute.

The accelerated approval process was established in 1992 for drugs that seemed more beneficial than existing therapies for life-threatening diseases, largely motivated by the emergence of HIV/AIDS. Accelerated approvals may be granted on the basis of surrogate endpoints such as disease-free survival or time to progression. But to keep the approval, sponsors must conduct confirmatory trials that document the drugs' actual benefit for overall survival or other more patient-centered outcomes.

Next Week

A Federal Appeals Court in Washington on Monday will hear arguments in a case over whether a company has the right to patent the BRCA1/2 gene sequences associated with breast cancer risk.

A U.S. District Judge ruled in 2010 that the gene sequences are products of nature identified purely by "abstract mental processes" and therefore ineligible for patent protection. He ruled that it was illegal for Myriad Genetics and the University of Utah Research Foundation to hold patents on the gene sequences.

The lawsuit was brought by the American Civil Liberties Union and the Public Patent Foundation against Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the genes, BRCA1 and BRCA2. The plaintiffs charge that the patents stifle diagnostic testing and research that could lead to cures and that they limit women's options regarding their medical care.

The Senate is expected to vote Tuesday on a bill that would eliminate the provision in the Affordable Care Act (ACA) that requires all businesses and property owners to fill out a tax form known as a "1099" each time they spend $600 or more.

Also on Tuesday, a House Oversight and Government Reform subcommittee will hold a hearing on "Waste, Abuse and Mismanagement in Government Health Care," and the Alliance for Health Reform will hold a briefing on the quality of children's' healthcare coverage.

Over at the FDA, the Anti-Infective Drugs Advisory Committee will discuss a new drug application for fidaxomicin for treatment of Clostridium difficile infection.

On Thursday and Friday, the Medicare Payment Advisory Commission will hold a meeting on physician payment issues.

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